Protocol Review and Monitoring System

PROJECT SUMMARY PROTOCOL REVIEW & MONITORING SYSTEM Moffitt Cancer Center’s (Moffitt) Protocol Review & Monitoring System (PRMS) supports rigorous review and monitoring of clinical studies through: 1) First Stage review by 16 Disease Groups; 2) Second Stage review by six Scientific Review Committee (SRCs); and 3) policy and ongoing portfolio review by the Clinical Research Action Committee (CRAC). The PRMS oversees the continuum, including scientific review, study prioritization, study amendment, and scientific progress. The SRCs maintain full authority for opening and closing clinical studies at Moffitt, thereby ensuring that each study meets its scientific and accrual goals. To fulfill its roles, PRMS activities are organized into four Specific Aims: Aim 1: To establish and maintain scientific review committees with sufficient size and expertise to conduct critical and fair scientific reviews of cancer-related research studies involving human subjects. Aim 2: To conduct a thorough scientific review of all non-peer reviewed cancer-related clinical studies based on specific, pre-determined review criteria. Aim 3: To prioritize all clinical studies. Aim 4: To monitor scientific progress for all ongoing clinical studies. New leaders conducted a comprehensive review and reorganization of clinical research processes, which include: 1) a revised Data & Safety Monitoring Plan (DSMP); 2) enhancements of trial review (establishing Disease Groups and Clinical Leads and revamping Scientific Review Committees); 3) enhanced rigor in trial review and monitoring; and 4) redeveloped efforts to reduce time to trial activation. Over the period, PRMS reviewed 2,048 protocols and 1,362 amendments, including 434 interventional studies. 642 studies (31% of all studies) were deferred or rejected in First Stage or Second Stage review. Additionally, 663 interventional studies have been opened with an average activation time of 135 days in the last quarter prior to the implementation of clinical research revenue cycle project (CRRC, noted in CPDM to have delayed activation due to having to put activation projects on hold as it was completed). The CRRC project is expected to reduce time to activation when completed. During the award period, Moffitt established the first NCI-approved multi-institutional scientific review committee for the Oncology Research Information Exchange Network (ORIEN), a national alliance of 18 cancer centers. This SRC is hosted and managed by Moffitt’s PRMS and comprises members from all participating institutions. PRMS ensures highly impactful and rigorous clinical research by providing scientific review, prioritization and monitoring of clinical studies with broad expertise across all areas of cancer research. This ensures that clinical research conducted at Moffitt continues to drive groundbreaking advances in the care and understanding of cancer in our catchment area and beyond.